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Chemistry Experts!

Product Development

Chemicals, polymer materials for medical devices

Technology assessments for fit and viability

Testing protocol development

Testing laboratory selection

Device performance protocols, design verification and validation

Safety testing strategies

Surface modification technologies, strategies

Medical device development regulations, documentation systems

Combination product design and development

 

Intellectual Property

Patent landscape preparation & review

Patentability assessment

Intellectual property strategy analysis

IP surveillance, updates and summary reports

Patent application drafting

Freedom-to-operate analysis

 

Manufacturing Support

Strategies and feasibility assessments

Chemicals & materials manufacturing guidance

Materials outsourcing

Materials qualification

Vendors & suppliers selection & qualification

Process verification, validation guidance

 

Quality Systems

FDA Quality System requirements and regulations

Quality Policy and Procedures documentation

Quality Control strategies and systems

ISO standards and strategies

FDA facility qualification and registration

Guidance on establishing development and testing laboratories

On-site training